PMA P060029
- Device
- ETHICON OMNEX SURGICAL SEALANT
- Applicant
- ETHICON, Inc.
- PMA number
- P060029
- Supplement
- S005
- Product code
- NBE
- Decision date
- 2014-01-17
- Generic name
- Sealant, polymerizing
- Approval order statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT ETHICON, INC., IN CORNELIA, GEORGIA.
Current openFDA PMA Record#
- Device
- ETHICON OMNEX SURGICAL SEALANT
- Applicant
- ETHICON, Inc.
- PMA number
- P060029
- Supplement
- S005
- Product code
- NBE
- Generic name
- Sealant, polymerizing
- Decision date
- 2014-01-17
- Decision code
- APPR
- Date received
- 2013-01-08
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT ETHICON, INC., IN CORNELIA, GEORGIA.